karenitecin in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer

Conditions: Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma

Summary: phase ii trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

objectives: i. determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer. ii. determine the toxicity of this drug in these patients. outline: this is an open-label study. patients receive karenitecin iv over 1 hour on days 1-5. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility criteria:
inclusion criteria: * histologically confirmed ovarian epithelial or primary peritoneal cancer * recurrent or persistent disease * platinum-resistant disease * at least 1 unidimensionally measurable lesion * at least 20 mm by conventional techniques or at least 10 mm by spiral ct scan * at least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target) * ineligible for a higher priority gog study or other phase ii cytotoxic study for platinum-resistant disease * performance status - gog 0-2 * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * bilirubin no greater than 1.5 times upper limit of normal (uln) * alt no greater than 2.5 times uln * alkaline phosphatase no greater than 2.5 times uln * creatinine no greater than 1.5 times uln * no myocardial infarction within the past 6 months * no cerebrovascular accident within the past 6 months * no transient ischemic attack within the past 6 months * no uncontrolled hypertension * no decompensated or uncontrolled chronic heart failure * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no neuropathy (sensory or motor) grade 2 or greater * no other invasive malignancies within the past 5 years except nonmelanoma skin cancer * no active infection requiring antibiotics * at least 3 weeks since prior biological or immunological agents * see disease characteristics * at least 3 weeks since prior chemotherapy and recovered * no more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen * no prior karenitecin or camptothecin analogue/derivative * at least 1 week since prior hormonal therapy * concurrent hormone replacement therapy allowed * see disease characteristics * at least 3 weeks since prior radiotherapy and recovered * no prior radiotherapy to more than 25% of marrow-bearing areas * recovered from recent surgery * at least 3 weeks since prior therapy directed at this malignancy * no prior anticancer therapy that would preclude study therapy * no concurrent amifostine or other protective reagents